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To follow the time-standard in Europe, for some years in Greenland we ha

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ve had light saving time every summer. The main reason is to follow the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

time in Europe.

The time in Greenland is 4 hours later than European ti

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e. That means when it is 12 o.clock in Europe, in Greenland it is 8 o.cl

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ock in the morning. This means that every day there is only 4 business-

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

hours, when offices are open both in Europe and in Greenland. If Greenl

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nd did not follow Europe, then when Europe shifts to summertime, We woul

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

d only have 3 business-hours together, which would be bad, as Greenland

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

has a close relationship to Denmark. Well, In Greenland not much light

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s saved by changing the time: In wintertime it is dark all day long, so

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

You have to have the electric light on all the time.

In summertime it i

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s bright light all night, so You do not need electric light at all. The

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

uestion of light saving has only reason for a short time in the spring a

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

nd in the fall. But Our community have big confusion every time the cloc

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

k is to be adjusted, and in addition there is always confusion and extr

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

expenses on services which are manned all night, such as hospitals, rad

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

io-stations and others.

My suggestion is, as the question of time is un

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

important, that in Greenland we maintain light saving time (summertime)

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ll year. This would give the extra advantage, that in wintertime there

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

would be not only 4 hours but 5 hours business-time together with Europe

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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